Chronic Hepatitis C Virus InfectionPhase 1/2NCT00563173
Phase I/IIa Dose Ranging CHRONVAC-C® Study in Chronic HCV Patients
A Phase 1/2 study testing CHRONVAC-C® in people with Chronic Hepatitis C Virus Infection, run by Tripep AB at 2 sites in Sweden.
Trial summary
The purpose of this study is to evaluate if the DNA vaccine CHRONVAC-C® intended for future treatment of Hepatitis C infections is safe and tolerated when administered to HCV infected individuals with a low viral load. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Hepatitis C Virus Infection
- What is being tested?
- CHRONVAC-C®
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesSweden
- Study dates
- Oct 2007to Apr 2010
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patient 18 -65 years of age with a known chronic hepatitis C infection.
- Genotype 1 infection.
- Viral load equal to or less than 800.000 IU/mL.
- BMI less than 30.
- Considered probable that the deltoid muscles (left and right) of the patient will be reached at vaccination using a 12.7 mm cannula for injection and a 15 mm applicator tip for electroporation.
- Written informed consent obtained, and a copy provided to the patient.
- Patient legally competent and able to communicate effectively with the study personnel.
- Patient likely to co-operate and attend the clinic at the appointed times during the study.
Who cannot join
- Patient having clinically significant concomitant diseases other than HCV in the medical history to the discretion of the investigator.
- Patient having clinically significant findings on physical examination, vital signs, ECG or clinical laboratory evaluations to the discretion of the investigator.
- Patient having clinical or biochemical signs of cirrhosis.
- Positive hepatitis B surface antigen (HBsAg).
- Positive HIV antigen or antibody test.
- Patient having an ongoing and/or known viral infection other than HCV that requires treatment and/or special medical intention.
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- Patient having received previous treatment for HCV.
- Radiation therapy or cytotoxic chemotherapeutic agents within 4 weeks prior to the first dose of study drug.
- Treatment with immunomodulating agents such as systemic corticosteroids, IL-2, IFN-alpha, IFN-beta, IFN-gamma within 4 weeks prior to the first dose of study drug.
- Treatment with NSAID within 10 days of the first dose of study drug.
- Immunization within 30 days of the first dose of the study drug.
- Patient having received an investigational drug product, or been enrolled in other investigational drug protocols within a period of 30 days prior to receiving the first dose of the study drug.
- Prior treatment with DNA therapy.
- Known allergy towards vaccines.
- Known abuse of alcohol, drugs or pharmaceuticals.
- History, signs or symptoms of a cardiac disease.
- Presence of an implantable pacemaker.
- Any metal implants within the treatment areas (close to the right and/or left deltoid muscles).
- Diagnoses of a serious psychiatric illness which may influence study participation.
- Female patient who is breast feeding.
- Female patient not clinically sterile (hysterectomy, tubal ligation or postmenopausal (amenorrhea > 1 year and FSH > 30 mU/ml) OR if not clinically sterile unwilling to use a reliable contraception method.
- Patient with a positive urine pregnancy test.
- Male patient unwilling to use condom for active prevention of pregnancy from first vaccination to 4 months after last injection.
- Patient or their immediate families being an investigator or site personnel directly affiliated with this study. Immediate family is defined as a spouse, parent, child or sibling, whether biologically or legally adopted.
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
I73 Department of Infectious Diseases, Karolinska Institute, Karolinska University Hospital, Huddinge
Stockholm, SE-141 86
Department of Gastroenterology and Hepatology, Karolinska University Hospital, Solna
Stockholm, SE-171 76
About this study
Official title: A Phase I/IIa Open-Label, Dose Ranging, Parallel, Safety, Tolerability and Efficacy Study of i.m. Administered CHRONVAC-C® in Combination With Electroporation in Chronic HCV Genotype 1 Infected and Treatment Naïve Patients With Low Viral Load
The purpose of this study is to evaluate if the DNA vaccine CHRONVAC-C® intended for future treatment of Hepatitis C infections is safe and tolerated when administered to HCV infected individuals with a low viral load. In addition the capability of the vaccine to induce an immune response and the effect on viral load will be studied. In order to increase the uptake of the vaccine the intra muscular injection is combined with electroporation, meaning that a brief electric field is applied to the injection site resulting in temporary pores in the cell membranes that allows the vaccine to enter the cells.
- Conditions
- Chronic Hepatitis C Virus Infection
- Being tested
- CHRONVAC-C®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHRONVAC-C®Drug
DNA vaccine, solution for injection, i.m. administration in combination with electroporation
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Low dose Receives: Drug: CHRONVAC-C® |
| 2 | Other | Medium dose Receives: Drug: CHRONVAC-C® |
| 3 | Other | High dose Receives: Drug: CHRONVAC-C® |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate safety and tolerability of electroporation mediated i.m. delivery of CHRONVAC-C® in chronically HCV infected, treatment naive patients with low viral load.
Measured: From start of treatment to 24 weeks post treatment
Secondary outcomes (1)
To provide information regarding dose related anti-viral immune response and dose related effect on viral load.
Measured: From start of treatment to 24 weeks post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2007 (estimated)
- Study startOct 2007
- Primary completionApr 2010 (estimated)
- Study completionApr 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis C Virus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tripep AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Inovio Pharmaceuticals
- Investigators
- Ola RH Weiland, Professor, Principal investigator, I73 Department of Infectious Diseases, Karolinska Institute, Karolinska University Hospital, Huddinge, SwedenAnders Vahlne, Professor, Study chair, Tripep ABMatti Sällberg, Professor, Study director, Tripep AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00563173
- Sponsor's protocol ID
- CVC-201
- Other IDs
- EudraCT No. 2007-002901-33
- Status last verified
- Feb 2010
- First submitted
- 23 Nov 2007
- Last updated
- 10 Feb 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/IIa Open-Label, Dose Ranging, Parallel, Safety, Tolerability and Efficacy Study of i.m. Administered CHRONVAC-C® in Combination With Electroporation in Chronic HCV Genotype 1 Infected and Treatment Naïve Patients With Low Viral Load
- ClinicalTrials.gov ID
- NCT00563173
- Acronym / sponsor ID
- CVC-201
- Conditions
- Chronic Hepatitis C Virus Infection
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Tripep ABIndustry (pharma, biotech, devices)
- Collaborators
- Inovio Pharmaceuticals
- Study start
- Oct 2007
- Primary completion
- Apr 2010 (estimated)
- Study completion
- Apr 2010 (estimated)
- First posted
- 26 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate if the DNA vaccine CHRONVAC-C® intended for future treatment of Hepatitis C infections is safe and tolerated when administered to HCV infected individuals with a low viral load. In addition the capability of the vaccine to induce an immune response and the effect on viral load will be studied. In order to increase the uptake of the vaccine the intra muscular injection is combined with electroporation, meaning that a brief electric field is applied to the injection site resulting in temporary pores in the cell membranes that allows the vaccine to enter the cells.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Drug: CHRONVAC-C®Low dose |
| 2 | Other | Drug: CHRONVAC-C®Medium dose |
| 3 | Other | Drug: CHRONVAC-C®High dose |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female patient 18 -65 years of age with a known chronic hepatitis C infection.
- Genotype 1 infection.
- Viral load equal to or less than 800.000 IU/mL.
- BMI less than 30.
- Considered probable that the deltoid muscles (left and right) of the patient will be reached at vaccination using a 12.7 mm cannula for injection and a 15 mm applicator tip for electroporation.
Key exclusion criteria (24 listed)
- Patient having clinically significant concomitant diseases other than HCV in the medical history to the discretion of the investigator.
- Patient having clinically significant findings on physical examination, vital signs, ECG or clinical laboratory evaluations to the discretion of the investigator.
- Patient having clinical or biochemical signs of cirrhosis.
- Positive hepatitis B surface antigen (HBsAg).
- Positive HIV antigen or antibody test.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CHRONVAC-C®DNA vaccine, solution for injection, i.m. administration in combination with electroporation | Drug | 1, 2, 3 |
Primary outcome
To evaluate safety and tolerability of electroporation mediated i.m. delivery of CHRONVAC-C® in chronically HCV infected, treatment naive patients with low viral load.
Time frame: From start of treatment to 24 weeks post treatment
1 secondary outcome
To provide information regarding dose related anti-viral immune response and dose related effect on viral load.
Time frame: From start of treatment to 24 weeks post treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ola RH Weiland, Professor principal investigator
I73 Department of Infectious Diseases, Karolinska Institute, Karolinska University Hospital, Huddinge, Sweden
Anders Vahlne, Professor study chair
Tripep AB
Matti Sällberg, Professor study director
Tripep AB
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CHRONVAC-C® in people with Chronic Hepatitis C Virus Infection, run by Tripep AB at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate safety and tolerability of electroporation mediated i.m. delivery of CHRONVAC-C® in chronically HCV infected, treatment naive patients with low viral load. (time frame: From start of treatment to 24 weeks post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2010.